The purpose of this study is to assess efficiency and safety of cryobiopsy compared to video-assisted thoracoscopic lung biopsy (VATS) in diagnosis of interstitial lung diseases (ILD). To that end, this non-interventional study prospectively collects data from patients undergoing routine diagnosis of ILD. In some of those patients less invasive diagnostic approaches do not yield a definitive diagnosis. Thus, they will ultimately be subjected to VATS if this procedure is reasonable. The information gained by this study will help to assess the significance of cryobiopsy in contrast to VATS in this particular disease group.

Further study details as provided by Wissenschaftliches Institut Bethanien e.V:

Primary Outcome Measures:

Rate of diagnostic cryobiopsies [ Time Frame: up to 3 days ]

For the individual study participant, the result of the cryobiopsy (whether it is diagnostically helpful, i.e. "diagnostic" or not, i.e. "inconclusive") will be documented when it is available, which will be within 3 days. The overall number of diagnostic cryobiopsies will be calculated once the study is complete.

Secondary Outcome Measures:

Rate of complications during cryobiopsy [ Time Frame: During and up to 48 hours after procedure ]

Number of complications associated with cryobiopsy, divided into three categories of severity: mild/moderate/severe

Rate of complications during VATS [ Time Frame: During and up to 10 days after procedure ]

Number of complications associated with VATS, divided into three categories of severity: mild/moderate/severe

Inability or contraindication to undergo any form of invasive diagnostic procedure associated with diagnosis of interstitial lung disease

Severely restricted CO diffusion capacity (<50%)

Pregnancy, lactation

Any medical, psychological or other condition restricting the patient's ability to provide informed consent

Participation in another clinical trial

Contacts and Locations

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Please refer to this study by its ClinicalTrials.gov identifier: NCT01714518